Lid retraction is a difficult problem encountered in oculofacial plastic surgery. It can result from previous surgery, radiotherapy or cicatrizing disease or it may be idiopathic. Whatever the aetiology, the cosmetic appearance is troublesome to patients and, can be damaging to the cornea. The definitive therapy for lid retraction is surgical, and often involves complicated procedures including tissue grafting.

Hyaluronic acid gels (HAG) have been FDA approved for the treatment of facial rhytids by subcutaneous injection and volume addition. These gels have gained wide popularity in for cosmetic applications in filling volume deficit areas. Functional applications in the periorbital area have also been described including the filling of volume deficit anophthalmic orbits, ectropion and loagophthalmos. Additionally, pilot studies have found HAG to be useful in correcting both upper and lower eyelid retraction, with good effect.

The purpose of this investigation is to define the clinical utility of HAG correction of lower eyelid retraction in terms of anatomic (lid position), quantitative (dry eye signs on cornea) and qualitative effects (symptom severity).

Patients in this arm will receive hyaluronic acid fillers to the lower lid.

Procedure: Hyaluronic acid

Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position

Other Name: Restylane

Sham Comparator: Saline

Procedure: Saline

Saline will be injected in to the lower lid, elevating it to a more anatomic position

Eligibility

Ages Eligible for Study:

21 Years to 65 Years (Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Lower eyelid retraction of >1mm in one or both eyes.

Complaints of either significant ocular symptoms (OSDI>13) or cosmetic deformity associated with the eyelid retraction.

Exclusion Criteria:

Age less than 21 years: due to lack of data on safety for HAG fillers in pediatric population

Age over 65 years of age: as HAG filler effect may be different in this population

Are pregnant or nursing: as there is little safety data on potential teratogenicity of HAG fillers

Have a demonstrated allergy to HAG fillers or lidocaine

Have a current infection, skin sore, pimple, rash, hive or cyst over the injection site: to avoid worsening the infection or transmitting it

Have a bleeding disorder or currently taking blood-thinning medications such as Coumadin or heparin on a daily basis.

Currently active stage Thyroid Eye Disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838252